Electrical Stimulation for Recovery of Hand Function in Chronic Stroke Survivors
NCT ID: NCT00891319
Last Updated: 2017-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2009-01-31
2015-05-31
Brief Summary
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Detailed Description
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The purpose of this study is to estimate the efficacy of Contralataterally Controlled Functional Electrical Stimulation (CCFES) in reducing upper extremity impairment and activity limitation in chronic upper extremity hemiplegia. CCFES is a rehabilitation intervention in which neuromuscular electrical stimulation (NMES) is applied to the finger and thumb extensor muscles of the paretic upper limb to open the hand. The stroke survivor controls the stimulation intensity, and consequent degree of hand opening, by modulating the degree of opening of the contralateral unimpaired hand, which is detected by an instrumented glove. Thus, volitional opening of the unaffected hand produces stimulated opening of the affected hand. The stimulation paradigm is used to assist the stroke survivor in practicing functional tasks with their affected hand. We will conduct a randomized controlled trial in which chronic stroke survivors (\>6 months post-stroke) will be randomly assigned to receive 12 weeks of CCFES or cyclic NMES, an intervention that provides electrical stimulation of the hand extensors, but with preprogrammed timing and intensity. Randomization will be stratified on two levels of baseline hand impairment defined by the degree of voluntary finger extension present. Assessments of upper extremity impairment and activity limitation will be made every 3 weeks during the treatment period and every 2 months during a 6-month follow-up period.
This study is the first randomized controlled trial of CCFES in chronic upper extremity hemiplegia. Ultimately, the information learned in this study will serve to accelerate the development of treatments for reducing post-stroke disability.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CCFES
CCFES - Contralaterally Controlled Functional Electrical Stimulation
* Electrical stimulator
* Stimulation to finger and thumb extensors only in response to, and with an intensity proportional to, opening of the contralateral unimpaired hand.
* A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity.
* Therapy sessions are done with the subject being assisted by the CCFES system.
Electrical stimulator
• 12-week intervention
1. Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.)
2. Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home.
cNMES
cNMES - Cyclic NeuroMuscular Electrical Stimulation
* Electrical stimulator
* Preprogrammed cycles of finger and thumb extensor stimulation repeatedly and automatically open the hand.
* Subject instructed to not move the contralateral arm/hand during stimulation.
* Therapy sessions are done without the stimulation system.
Electrical stimulator
• 12-week intervention
1. Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.)
2. Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home.
Interventions
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Electrical stimulator
• 12-week intervention
1. Therapist-guided task practice performed twice a week in the research laboratory. (Device used for CCFES group but not for cNMES group during these sessions.)
2. Self-administered CCFES or cNMES-mediated hand opening exercise performed 10 sessions per week at home.
Eligibility Criteria
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Inclusion Criteria
* \> 6 months of first hemorrhagic or nonhemorrhagic stroke
* Able to recall 2 of 3 items after 30 minutes
* MRC ≤ 4 for finger extensors on paretic side
* Able to follow 3-stage commands
* Functional movement of shoulder and elbow (e.g., can reach ¾ hand-to- mouth movement) of paretic side
* Caregiver available to assist with device and compliance if needed
* Skin intact on hemiparetic arm
* Medically stable
* Surface NMES trial opens hand without pain
* Full volitional hand opening/closing of contralateral hand
* Upper extremity hand section of FMA \< 11/14
* Able to hear and respond to stimulator/cue box auditory cues
* Completed occupational therapy (no concomitant OT)
Exclusion Criteria
* Severe shoulder or hand pain (unable to position hand in the workspace without pain)
* Uncontrolled seizure disorder
* Insensate forearm and/or hand
* Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
* Edema of the affected forearm and/or hand
* History of cardiac arrhythmias with hemodynamic instability
* Cardiac pacemaker or other implanted electronic system
* Pregnant
* IM Botox injections in any UE muscle in the last 3 months
* Parkinson's disease, SCI, TBI, or MS
* Ipsilateral motor neuron lesion
18 Years
80 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Case Western Reserve University
OTHER
MetroHealth Medical Center
OTHER
Responsible Party
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Jayme Knutson
Assistant Professor, Physical Medicine and Rehabilitation
Principal Investigators
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Jayme S. Knutson, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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References
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Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.
Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.
Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9. doi: 10.1161/01.str.29.5.975.
Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.
Whitall J, McCombe Waller S, Silver KH, Macko RF. Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke. 2000 Oct;31(10):2390-5. doi: 10.1161/01.str.31.10.2390.
Mudie MH, Matyas TA. Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disabil Rehabil. 2000 Jan 10-20;22(1-2):23-37. doi: 10.1080/096382800297097.
Knutson JS, Gunzler DD, Wilson RD, Chae J. Contralaterally Controlled Functional Electrical Stimulation Improves Hand Dexterity in Chronic Hemiparesis: A Randomized Trial. Stroke. 2016 Oct;47(10):2596-602. doi: 10.1161/STROKEAHA.116.013791. Epub 2016 Sep 8.
Related Links
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Cleveland FES Center
The MetroHealth System - Clinical Trials